A Precautionary Approach to Genetically Modified Organisms: Challenges and Implications for Policy and Science

The commercial introduction of genetically modified organisms (GMOs) has revealed a broad range of views among scientists and other stakeholders on perspectives of genetic engineering (GE) and if and how GMOs should be regulated. Within this controversy, the precautionary principle has become a contentious issue with high support from skeptical groups but resisted by GMO advocates. How to handle lack of scientific understanding and scientific disagreement are core issues within these debates. This article examines some of the key issues affecting precaution as a legal standard and as an approach to the use of science in decision-making processes. It is pointed out that there is a need for reflection over the level of scientific evidence required for applying the precautionary principle as well as who should have the burden of proof when there are uncertainties. Further, an awareness of the broader scientific uncertainties found in GMO risk assessment implies that a precautionary approach must be elaborated: both for acknowledging uncertainties and for identification of scientific responses. Since precaution is an important issue within the sustainable development framework, it is suggested that sustainability can provide a normative standard that can help to reveal the influence and negotiate the importance of the various forms of uncertainty. Wise management of uncertainties and inclusion of normative aspects in risk assessment and management may help to ensure sustainable and socially robust GMO innovations at present and in the future.     

Global Trade in GM Food and the Cartagena Protocol on Biosafety: Consequences for China

The UN Cartagena Protocol onBiosafety adopted in Montreal, 29 January, 2000and opened for signature in Nairobi, 15–26 May,2000 will exert a profound effect oninternational trade in genetically modifiedorganisms (GMOs) and their products. In thispaper, the potential effects of variousarticles of the Protocol on international tradein GMOs are analyzed. Based on the presentstatus of imports of GMOs and domestic researchand development of biotechnology in China,likely trends in imports of foreign GM food andrelated products after China accedes to WTO isexplored. Also, China's potentialcountermeasures to control and regulate importsof GMOs in line with implementation of theProtocol are discussed. China, in recent times,has increased its food and agricultural importssubstantially from USA and Canada. Chinaimported soybean 10.42 mill. tons in 2000 andabout 15 mill tons in 2001, of which majorityare from USA where GM soybean accounts for60%. The plantation of US Monsanto'stransgenic Bt cotton was increased to more than1 million ha in China in 2001. Though China haspaid great attention to develop biotechnology,it appears to have little scope to export GMOsand GM products. So China may consider a rangeof administrative measures to implement theCartagena Protocol and to regulate its importof GMOs and GM agricultural products.Consequently, the Regulation on Safety ofAgri-GMOs was issued on June, 2001 and followedthree detailed rules issued in Jan. of 2002,with a priority to limit foreign GMOs importingby safety certification and labeling system.These were outlined taking into accountpolicies adopted in Western countries such asgreen barriers to international trade.     

Ethics in the Societal Debate on Genetically Modified Organisms: A (Re)Quest for Sense and Sensibility

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously.     

GMOs and Global Justice: Applying Global Justice Theory to the Case of Genetically Modified Crops and Food

Proponents of using genetically modified (GM) crops and food in the developing world often claim that it is unjust not to use GMOs (genetically modified organisms) to alleviate hunger and malnutrition in developing countries. In reply, the critics of GMOs claim that while GMOs may be useful as a technological means to increase yields and crop quality, stable and efficient institutions are required in order to provide the benefits from GMO technology. In this debate, the GMO proponents tend to rely on a simple utilitarian type of calculus that highlights the benefits of GMOs to the poor, but that overlooks the complex institutional requirements necessary for GMO production. The critics, recognizing the importance of institutional conditions, focus primarily on the negative impacts of institutional deficiencies, thereby overlooking the basically Rawlsian claim that institutions per se may generate claims to justice. This article investigates how GMOs might generate claims to global justice and what type of justice is involved. The paper argues that the debate on GMOs and global justice can be categorized into three views, i.e., the cosmopolitan, the pluralist, and the sceptic. The cosmopolitan holds that GMOs can and should be used for alleviating global hunger, whereas the sceptic rejects this course of action. I will argue here for a moderately cosmopolitan approach, relying on the pluralist view of institutions and the need to exploit the benefits of GMOs. This argument rests on the premise that global cooperation on GMO production provides the relevant basis for assessing the use of GMOs by the standard of global distributive justice.     

Sustainable Development and Norwegian Genetic Engineering Regulations: Applications, Impacts, and Challenges

The main purpose of The NorwegianGene Technology Act (1993) is to enforcecontainment of genetically modified organisms(GMOs) and control of GMO releases.Furthermore, the Act intends to ensure that``production and use of GMOs should take placein an ethically and socially justifiable way,in accordance with the principle of sustainabledevelopment and without detrimental effects tohealth and the environment.' Hence it isobvious that, for the Norwegian authorities,sustainable development is a normativeguideline when evaluating acceptableconsequences of GMO use and production. Inaccordance with this, we have investigated theextent to which the sustainability criteriawere decisive for the destiny of one approvedand one declined application of geneticallymodified plant release. The presentunderstanding of the ecological,socio-economical, and cultural consequences ofGMO use and release is fragmentary anduncertain. We consider the PrecautionaryPrinciple and the notion of equitabledistribution as key issues within thesustainable development framework, henceconstituting important foundations for ouranalyses. The Act is legitimizingsustainability criteria, but does not seem tosecure their conversion into concrete action.We envisage a more conscious implementation ofthe Norwegian Gene Technology Act.Sustainability concerns ecological, economical,and social values, and these can only beensured through long-term thinking, initiationof independent risk-associated research, andbroad involvement of all stakeholders in theevaluation of GMO issues and concerns.     

Aircraft and road traffic noise exposure and children's mental health

There have been few studies examining noise and psychological disorders in children and the results are equivocal. The objective of this study was to examine exposure–effect relationships between aircraft and road traffic noise exposure and children's mental health. We conducted a cross-national, cross-sectional study assessing 2844 pupils, aged 9–10, from 89 schools around three major airports in the Netherlands, Spain and United Kingdom matched within country for socio-economic position. We selected children on the basis of exposure to external aircraft and road traffic noise exposure. The Strengths and Difficulties Questionnaire (SDQ) assessed child mental health, including emotional problems, conduct disorder, hyperactivity, peer problems and prosocial behaviour. Aircraft noise exposure was significantly associated with an increased score on the hyperactivity subscale (pooled B estimate 0.013 CI 0.007–0.019) after full adjustment. Road traffic noise was significantly associated with lower scores on the conduct problems subscale maintained after full adjustment (pooled B estimate 0.010 95%CI −0.020 to −0.001). There was no association between either aircraft or road traffic noise exposure and the SDQ total score. The hyperactivity results have been found in a previous UK study and may indicate that high aircraft noise exposure exacerbates hyperactivity symptoms in children although this finding requires further replication.     

Heterogeneous and unconventional coalitions around global food risks: integrating Brazil into the debates

Current debates about food-borne risks (GMOs and BSE) have not only deepened public concern about how food is produced on farms, processed in factories, and transported, stored and traded. More importantly, these debates have exposed a crisis related to central social issues, such as the role of science, politics and business corporations in the decision-making processes for determining which risks societies should, or are prepared to, assume. In this article, I discuss how cultural and social constructivist studies of environmental and health risks and Ulrich Beck's theory of world risk society can contribute to the analysis of how to deal with these conflicts. The criticism of quantitative methods of risk analysis has resulted in a certain idealization of the lay knowledge of risks as being intuitively more correct than the scientific one. One consequence of this polarization between expert and lay knowledge—idealizing the latter—is a disappointing vagueness when looking for alternatives on how to deal practically with risks that have important consequences. A key obstacle to the implementation of some of the suggestions presented by the critical risk analysis approach is that, for example, in the current global dynamics of food-borne risks we can find heterogeneous alliances for and against GMOs allying lay people and experts, as well as conventional and unconventional social actors, in a complicated manner, at the regional, national and international levels. Since a significant part of the analysis of manufactured risks focuses on the situation of highly industrialized countries, a more complex perspective of these lay and scientific alliances can be obtained from a more extensive study of the reactions surrounding GMOs and BSE in less-industrialized countries, such as Brazil. Copyright © 2002 John Wiley & Sons, Ltd.     

Putting Precaution to Debate – about the Precautionary Principle and Participatory Technology Assessment

Technology assessment (TA) as aninstitution was introduced nearly thirty yearsago as an instrument to render possible themaking of responsible decisions concerning newtechnological options. Another recentdevelopment however has been the introductionof participatory technology assessment (pTA),mainly connected to the growing insight thatthe evaluation of technological options withrespect to their risks and benefits, is not –only – a scientific question. This paper willfocus on the questions, to what degree theideas of technology assessment and thePrecautionary Principle are connected and how.Without naming it explicitly, the PrecautionaryPrinciple is put to debate in the``TA-arrangement on the cultivation oftransgenic herbicide resistant crops,'organized by the Science Centre, Berlin. Fromthe perspective of ethical clarification, someunique features concerning theconceptualization of the discoursive procedureand reconstruction of the argumentation processin order to come to results have to beanalyzed. Finally the performance and resultsof the pTA-arrangement are reflected in thelight of the Precautionary Principle andconclusions are drawn.     

Managing the potential public health risks from bioaerosol liberation at commercial composting sites in the UK: An analysis of the evidence base

The diversion of biodegradable waste from landfill is of key importance in developing a sustainable waste strategy for the next decade and beyond. The proliferation of waste treatment technologies such as Mechanical Biological Treatment, Anaerobic Digestion and Composting will be paramount in achieving this strategic goal. This paper evaluates the scientific information needed to undertake an effective assessment of the potential public health risks from exposure to bioaerosols in the vicinity of commercial composting activities. Knowledge gaps currently exist in the scientific and regulatory community that limit our ability to effectively characterise source-term emissions, develop reliable dose–response data and accurately model the dispersion of bioaerosols. Consequently reliable risk estimates cannot be developed to inform the management of these potential risks. This uncertainty may prove a barrier to progress in achieving waste diversion and composting targets in Wales and the rest of the UK. A robust and extensive evidence base is required to inform the risk assessment process. This paper advocates the need for further, more focussed research into hazard characterisation of viable and non-viable organisms, improved dose–response data, exposure assessment techniques and an evaluation of the existing risk control and mitigation measures currently adopted. It is hoped that his will enable effective, timely and proportional risk management and mitigation measures to be developed that will foster the confidence required in composting technologies to achieve waste diversion targets and develop sustainable waste strategies.     

The case for regulating intragenic GMOs

This paper discusses the ethical and regulatory issues raised by “intragenics” – organisms that have been genetically modified using gene technologies, but that do not contain DNA from another species. Considering the rapid development of knowledge about gene regulation and genomics, we anticipate rapid advances in intragenic methods. Of regulatory systems developed to govern genetically modified organisms (GMOs) in North America, Europe, Australia, and New Zealand, the Australian system stands out in explicitly excluding intragenics from regulation. European systems are also under pressure to exclude intragenics from regulation. We evaluate recent arguments that intragenics are safer and more morally acceptable than transgenic organisms, and more acceptable to the public, which might be thought to justify a lower standard of regulation. We argue that the exemption of intragenics from regulation is not justified, and that there may be significant environmental risks associated with them. We conclude that intragenics should be subject to the same standard of regulation as other GMOs.     

The US’ Food and Drug Administration, Normativity of Risk Assessment, GMOs, and American Democracy

The process of risk assessment of biotechnologies, such as genetically modified organisms (GMOs), has normative dimensions. However, the US’ Food and Drug Administration (FDA) seems committed to the idea that such evaluations are objective. This essay makes the case that the agency’s regulatory approach should be changed such that the public is involved in deciding any ethical or social questions that might arise during risk assessment of GMOs. It is argued that, in the US, neither aggregative nor deliberative (representative) democracy ought to be used to make such determinations. Instead, participatory (deliberative) democracy should be the means by which members of the polity decide which normative concerns ought to underlie FDA’s assessment of GMOs. This paper uses a hypothetical case involving a new GM seed to make that argument.     

Model Computations on Sequestration of Carbon in Managed Forests and Wood Products under Changing Climatic Conditions in Finland

The aim of this study was to assess the effects of forest management on carbon sequestration in forests and wood products by using a gap-type forest model interfaced with a wood product model. The assessment is based on total carbon sequestration, i.e. the amount of carbon left in vegetation, litter, soil organic matter and products when the flows of carbon back to the atmosphere have been subtracted. Thirty mixed-species stands, representing medium fertility sites in southern Finland, were included in each simulation for 300 years under current climatic conditions and predicted conditions of changing climate. The average total balance for the first 100 years was higher in the unmanaged system than in the managed system, but for the second and third 100-year periods the results were clearly opposite. Differences in the total balance between the treatments were larger during the first 100 years than over the whole 300-year period. Under conditions of changing climate, differences in carbon sequestration between management options were more pronounced than under current climatic conditions. Under current climatic conditions with the 100-year time frame, the ratio between the total annual balance and annual gross production was 0·208–0·289. Over the whole 300 years, however, efficiency was much lower, 0·088–0·121. Under changing climatic conditions, efficiency was also lower, 0·182–0·252 and 0·081–0·096, respectively. Different management alternatives clearly produced different amounts of timber for the production process; under conditions of changing climate, timber production was substantially enhanced. However, total carbon storages at the end of the simulation varied less than timber production. In the managed system, the flow back into the atmosphere was largest from litter, 41–51% of the total outflow, the flow from vegetation was 23–28%, from soil organic matter 22–25%, emissions from products 1–7%, and emissions from landfills 0–3%. If emissions due to the use of machinery in timber harvesting and transportation were included, they made up only 0·03–0·33% of the total outflow.     

Emissions from burning biofuels in metal cookstoves

Promoting stoves that burn wood and other biofuels more efficiently is one of the means to reduce fuel consumption, but such efficient stoves may also emit more carbon monoxide and total suspended particulates. In an earlier study, a standard chamber method was proposed to estimate emission factors from burning fuelwood (Acacia nilotica). Here that methodology is extended to measure emission factors from burning of dungcakes and crop residues (Brassica or mustard stalks)—common fuels in many developing countries. The amounts of carbon monoxide (CO) and total suspended particulates (TSP) emitted by four different models of stoves, when using each of the three biofuels, are measured.The CO emission factors range from 13–68 (g/kg) for fuelwood to 26–67 g/kg for dungcakes and 20–114 g/kg for crop residues, for particulates they range from 1.1–3.8 to 4.1–7.8 and 2.1–12.0 g/kg for the three fuels, respectively. On a per unit heat delivered basis, the emissions of CO and TSP from both dungcakes and crop residues are two to three times higher compared to those from fuelwood. While for some improved stove-fuel combinations, the increase in emission factors was offset by the increase in thermal efficiency, this was not always so and causes a dilemma. The more efficient stoves are found to have higher emission factors of both CO and TSP for all three fuels. Emissions per standard task (i.e, on a unit heat delivered basis) is proposed as a criterion to evaluate cookstoves.     

Food, Consumer Concerns, and Trust: Food Ethics for a Globalizing Market

The use of biotechnology in food productiongives rise to consumer concerns. The term ``consumerconcern' is often used as a container notion. Itincludes concerns about food safety, environmental andanimal welfare consequences of food productionsystems, and intrinsic moral objections againstgenetic modification. In order to create clarity adistinction between three different kinds of consumerconcern is proposed. Consumer concerns can be seen assigns of loss of trust. Maintaining consumer trustasks for governmental action. Towards consumerconcerns, governments seem to have limitedpossibilities for public policy. Under current WTOregulations designed to prevent trade disputes,governments can only limit their policies to 1) safetyregulation based upon sound scientific evidence and 2)the stimulation of a system of product labeling. Ananalysis of trust, however, can show that ifgovernments limit their efforts in this way, they willnot do enough to avoid the types of consumer concernsthat diminish trust. The establishment of a technicalbody for food safety – although perhaps necessary –is in itself not enough, because concerns that relatedirectly to food safety cannot be solved by ``pure'science alone. And labeling can only be a good way totake consumer concerns seriously if these concerns arerelated to consumer autonomy. For consumer concernsthat are linked to ideas about a good society,labeling can only provide a solution if it is seen asan addition to political action rather than as itssubstitution. Labeling can help consumers take uptheir political responsibility. As citizens, consumershave certain reasonable concerns that can justifiableinfluence the market. In a free-market society, theyare, as buyers, co-creators of the market, andsocietal steering is partly done by the market.Therefore, they need the information to co-create thatmarket. The basis of labeling in these cases, however,is not the good life of the individual but thepolitical responsibility people have in their role asparticipants in a free-market. Then, public concernsare taken seriously. Labeling in that case does nottake away the possibilities of reaching politicalgoals, but it adds a possibility.     

Birds and air traffic safety on Zagreb airport (Croatia)

One of the objectives of the new State of Croatia, as a Mediterranean country oriented towards tourism, is safety of its air traffic. The frequency of use of Zagreb airport is currently 688 flights, or about 20000 passengers a week. In 1996, research was carried out at the airport concerning air traffic safety with respect to the presence of birds on the airfield. Biological methods, in which birds were chased away by means of trained birds of prey, were used. For the Zagreb airport experiment nine birds involving three different species: Falco peregrinus, Accipiter gentilis and Falco cherrug were utilised. The results showed that the air traffic safety on Zagreb airport with regard to possible bird-plane strikes improved.Other bird clearing methods, applied over the 1987–1996 period also reduced bird-plane interferences but were noted to be less effective. With the biological, bird of prey method, 100% temporary clearance was achieved. Habitat modification, which involved removal from the airport vicinity of all factors attractive to the birds, only removed 20–30% of the birds, but this was of a more permanent nature. Use of fire-arms achieved a 80–90% temporary bird clearance. A combination of all three methods would appear to be most effective and measures for further monitoring for safe air traffic movement at Zagreb airport are proposed.     

Acid-forming emissions in Alberta,Canada

The sulphur dioxide and nitrogen oxides emissions from all sources in Alberta, Canada, during 1982 amounted to 488,297 and 353,511 tonnes, respectively. During this year deposition of wet sulphate from all stations in the province, 8 kg ha^–1 yr^–1, compares well with the five-year average (1978–1982) value of 10 kg ha^–1 yr^–1. These measurements are about one-half of the wet sulphate deposition criteria of 20 kg ha^–1 yr^–1 established for protecting the moderately sensitive aquatic ecosystem in eastern Canada. Due to dry, cold, continental climate conditions of Alberta, dry sulphate or sulphur deposition is equally or more important than wet deposition. No effects of the long-range transport of atmospheric pollutants (LRTAP) on the ecosystems in Alberta have been observed to date. Atmospheric deposition target loadings of SO₄ ^–2, NO₃ ^–, and H⁺ for Alberta and western Canadian environmental conditions should be developed to protect the highly sensitive ecosystems. Some future research and monitoring priorities for Alberta and western Canada are outlined.     

Filling the Gaps in the Risks vs. Benefits of Mammalian Adult-Cell Cloning: Taking Bernard Rollin's Philosophy Its Next Step

A critique is made of Bernard Rollin's examination of the ethics of cloning adult mammalian cells. The primary concern is less to propound an anticloning or procloning position than to call for full exploration of the ethical complexities before a rush to judgment is made. Indeed, the ethical examination in question rushes toward an ethical position in such a way that does not appear consistent with Rollin's usual methodology. By extending this methodology – which entails full weighing of benefits and costs – it becomes apparent that there are real potential risks to this type of cloning in both animals and humans, besides the possible benefits, and that the scientific, political, philosophical, and broader academic communities should explore these risks and benefits extensively. Rollin's usual methodological call for hesitation before risks would translate into hesitation before the ethical risks of adult mammalian cell cloning instead of his paper's curiously laissez-faire stance.     

Public concerns and the public role in siting nuclear and chemical waste facilities

Nuclear and chemical waste facilities can be successfully sited, despitenimby responses, if siting programs account for the sources of public concern. Irrational fear is not the main source; instead, waste managers must deal with perceived inequities in the distribution of benefits and costs, and concern about facility safety. Benefit-cost inequities may be dealt with in part by keeping wastes where they are generated, through political restrictions, or by providing economic compensation and political incentives (for example, a local veto). Assuring people of facility safety includes allowing local control (monitoring, health assessment, regulation), and enhancing trust of facility managers through such means as rectifying past mistakes, individual-oriented education campaigns, and negotiation of compensation packages with local residents. These means should reduce —without eliminating—public opposition to local siting of nuclear and chemical waste facilities.     

GIS-based assessment of the threat to world forests by patterns of non-sustainable civilisation nature interaction

The paper presents a novel transdisciplinary approach to investigate non-sustainable civilisation–nature interactions in the context of global change. The approach rests on the decomposition of intricate dynamics of Global Change into problematic patterns civilisation nature interactions (‘syndromes’) this is done by an iterative process of observations, data and theoretical system analysis and GIS-based modelling attempts. These syndromes of global change characterise endangering and risky developments of civilisation nature interaction and represent a baseline for measuring and indicating ‘non-sustainability’; in order to have a sustainable development it is necessary to have a far-reaching absence of syndromes. They encompass the core problems of global change, e.g. soil degradation, climate change, threats to biodiversity or global deforestation. Patterns are defined as characteristic constellations of global change trends (‘symptoms’). Cause–effect schemes of symptoms and their interrelations are constituted as complex phenomena resulting from interactions over the different spheres of the Earth system (biosphere, atmosphere, hydrosphere, population, pedosphere, economy, psychosocial sphere, social organisation, science and technology). The approach is illustrated by an analysis of civilisation–nature interaction patterns relevant for global deforestation. Global forest ecosystems have been chosen for this investigation because of their important role in the global carbon cycle and their importance for biological diversity. The resulting geographical patchwork of the combined dispositions and intensities of the different syndromes describes current and future regional threats to forests by their underlying global cause–effect patterns of civilisation–nature interaction.     

Science and the Consequences of Mistruct: Lessons from Recent GM Controversies

In 2001, it was announced thattransgenic DNA had introgressed intotraditional strains of maize in Mexico. Acontroversy erupted and raged throughout 2001and 2002. This episode represents an acutebreakdown in scientific discourse. Given thestakes in the genetically modified organismdebate, a breakdown in scientific discourse isalarming. The following inquiry looks into thecauses of this breakdown. Ultimately, it willbe argued that the underlying problem is thecurrent institutional structure of science,particularly in the United States. If thediagnosis is correct, then the proper course oftreatment is to pursue a program ofinstitutional reconstruction.